Cleared Traditional

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01

K072036 · Biokit, S.A. · Toxicology
Mar 2008
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K072036 is an FDA 510(k) clearance for the ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on March 19, 2008, 238 days after receiving the submission on July 25, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K072036 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2007
Decision Date March 19, 2008
Days to Decision 238 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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